Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety (NCT02810171) | Clinical Trial Compass
CompletedNot Applicable
Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety
United States207 participantsStarted 2016-12
Plain-language summary
Anxiety is among the most prevalent, costly and disabling illnesses and tends emerge early in childhood. Cognitive behavioral therapy (CBT) is the first-line treatment for early life anxiety, but as many as 40% of young patients who receive CBT fail to get better. The proposed study will examine brain changes marking positive response to CBT for anxiety and how these changes may differ in children compared adolescents. By helping us to understand how CBT works, this study will pave the way for new treatments to stop anxiety early.
Who can participate
Age range7 Years – 17 Years
SexALL
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Inclusion Criteria for all participants (Clinically Anxious and Healthy):
* Age 7.0 - 17.99 years
* Parent or guardian able and willing to give informed consent
* Ability to tolerate small, enclosed spaces
Exclusion criteria for all participants (Clinically Anxious and Healthy)
* No metals, implants or metallic substances within or on the body (e.g., orthodontic braces)
* Vision equal to or better than 20/30 on a Snelling chart, with correction if necessary
* Not currently taking any psychotropic medication or receiving any psychotherapy (stable doses of stimulants allowable for anxiety subjects with comorbid attention deficit hyperactivity disorder) or receiving hormone therapy other than birth control
* No lifetime diagnoses of psychotic disorder, mental retardation or autism
* No history of current substance/alcohol abuse/dependence
* No evidence of suicidal intentions or behaviors in the past 6 months
* No history of serious medical or neurological illness
* If post-pubertal female, not pregnant
Additional Inclusion Criteria for Clinically Anxious Participants:
* Clinically significant anxiety as determined by structured clinical interview
* Past history of major depressive episodes are allowable
* Past history substance/alcohol abuse allowable if in remission for at least 1 year
* Obsessive-compulsive disorder symptoms are acceptable if not the primary source of interference or distress
* Anxiety must be primary concern, still bothersome, and CBT for anxiety determi…
What they're measuring
1
Brain function/structure as assessed by Magnetic Resonance Imaging scans